DEVICE: EKG Patch Solution (00860007764424)
Device Identifier (DI) Information
EKG Patch Solution
1
In Commercial Distribution
EPSK001CLPA020MG
Mg Medical Products LLC
1
In Commercial Distribution
EPSK001CLPA020MG
Mg Medical Products LLC
Portable, 12-lead ECG testing kit.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No | |
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No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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11413 | Electrocardiograph, professional, single-channel |
A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OEZ | Cardiovascular Procedure Kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 500 and 1060 millibar |
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 27 Degrees Celsius |
Special Storage Condition, Specify: Keep away from sunlight. |
Special Storage Condition, Specify: Keep dry. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1b7cc7a5-871a-4f7b-a095-966584cf6e80
January 17, 2025
1
January 09, 2025
January 17, 2025
1
January 09, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined